Requirements: English
Company: JR Italy
Region: Udine , Friuli-Venezia Giulia
Social network you want to login/join with:Job Description: CSV-DI Systems ConsultantWe are seeking a consultant with expertise in CSV-DI to conduct a detailed gap assessment of all legacy integrated and stand-alone systems in our GMP production facility. The assessment will include a comprehensive report and risk analysis to inform investment prioritization. Please note that QC lab systems are excluded from this assessment, as they are considered to be near the ''state of the art''. The scope is limited to systems in the production areas for oral dosage form products; sterile experience is not required.Responsibilities:Perform a gap assessment of stand-alone and integrated systems, focusing on:Assessing each systems compliance level and associated risksMapping which legacy systems can continue to be used, require minor modifications, or need replacement/upgradesDeveloping risk assessments for systems that cannot be retained, to guide investment decisionsProducing a detailed CSV-DI gap assessment reportIdeal Candidate Profile:Minimum of 5+ years experience in CSV-DIPrevious experience in similar assessments is preferredItalian language skills are a plus but not mandatoryAvailability to visit onsite as needed, primarily to gather documentation of non-integrated/standalone systems#J-18808-Ljbffr